# Evaluation of Safety and Pharmacokinetics of Oral Controlled-ileal-release Nicotinic Acid (CIR-NA) Compared to Immediate-release Nicotinic Acid and Placebo in Healthy Subjects and Subjects With Prediabetes

> **NCT06378125** · PHASE1 · COMPLETED · sponsor: **University Hospital Schleswig-Holstein** · enrollment: 60 (actual)

## Conditions studied

- Safety Issues
- Pharmacokinetic

## Interventions

- **DRUG:** controlled-ileal-release nicotinic acid (SAD/ MAD/MD) single- and multiple-ascending dose (SAD/MAD) or multiple dose (MD)
- **DRUG:** immediate-release nicotinic acid (SAD)
- **DRUG:** Placebo controlled-ileal-release nicotinic acid (SAD/MAD)
- **DRUG:** Placebo immediate-release nicotinic acid (SAD)

## Key facts

- **NCT ID:** NCT06378125
- **Lead sponsor:** University Hospital Schleswig-Holstein
- **Sponsor class:** OTHER
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2022-12-19
- **Primary completion:** 2024-11-12
- **Final completion:** 2024-11-12
- **Target enrollment:** 60 (ACTUAL)
- **Last updated:** 2024-11-27


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06378125

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06378125, "Evaluation of Safety and Pharmacokinetics of Oral Controlled-ileal-release Nicotinic Acid (CIR-NA) Compared to Immediate-release Nicotinic Acid and Placebo in Healthy Subjects and Subjects With Prediabetes". Retrieved via AI Analytics 2026-06-09 from https://api.ai-analytics.org/clinical/NCT06378125. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
